Phase 1 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with breast cancer that is hormone receptor positive (HR+) and HER2 negative, and where the cancer has spread locally, come back, or spread to other parts of the body
• People who have received no more than 3 previous treatment courses for their advanced or spread cancer
• People who are willing and able to sign a written consent form for the study
• People who are 18 years of age or older at the time of signing consent
• People whose cancer has a specific gene change called a PIK3CA mutation or amplification, confirmed by an accredited diagnostic laboratory using an approved test
• People whose cancer can be measured or assessed using standard imaging criteria (called RECIST 1.1)
• People who are generally well enough to carry out light activity and care for themselves (confirmed with trial site)
• People whose treating doctor estimates they have a life expectancy of at least 6 months
• People with adequate bone marrow, liver, and kidney function, tested within 14 days before the first study treatment
• People whose fasting blood sugar level is at or below 140 mg/dL and whose longer-term blood sugar measure (HbA1c) is at or below 7.0%
• People who have a stored or freshly collected tumour tissue sample available for testing at the central laboratory

Who may not be able to join:

• People who have been diagnosed with Type 1 diabetes, or who have Type 2 diabetes that is not well controlled
• People with cancer that has actively spread to the brain or central nervous system
• People whose cancer has a specific gene change called a PTEN mutation

Important: Always verify eligibility with the trial site directly before applying.